Evidence map›Paper›PMID 23060038›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2012

A phase III skin cancer chemoprevention study of DFMO: long-term follow-up of skin cancer events and toxicity.

Sarah M Kreul, Tom Havighurst, KyungMann Kim, Eneida A Mendonça, Gary S Wood, Stephen Snow, Abbey Borich, Ajit Verma, Howard H Bailey

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Guidelines of care for the management of cutaneous squamous cell carcinoma.Journal of the American Academy of Dermatology · 2018
    Guideline
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Antitumor potential of polyamines in cancer.Acta biochimica et biophysica Sinica · 2025
    Review
  7. Article
  8. The MUC1-HIF-1α signaling axis regulates pancreatic cancer pathogenesis through polyamine metabolism remodeling.Proceedings of the National Academy of Sciences of the United States of America · 2024
    Article
  9. Review
  10. An update on clinical trials for chemoprevention of human skin cancer.Journal of cancer metastasis and treatment · 2023
    Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Chemoprevention of gastrointestinal neoplasia.Current gastroenterology reports · 2013
    Review
  19. Article
  20. Difluoromethylornithine: the proof is in the polyamines.Cancer prevention research (Philadelphia, Pa.) · 2012
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Sarah M KreulUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.
Tom Havighurst
KyungMann Kim
Eneida A Mendonça
Gary S Wood
Stephen Snow
Abbey Borich
Ajit Verma
Howard H Bailey
University of Wisconsin Carbone Cancer Center · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Christian Capitini · 1985 to 2026
$142.6M
CHEMOPREVENTION OF SKIN CANCER--DFMO PHASE 3 TRIALU01CA077158 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI BAILEY, HOWARD H · 1997 to 2002
$1.2M
Chemoprevention of Skin Cancer - DFMO Phase III TrialR01CA077158 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI BAILEY, HOWARD H · 2004 to 2005
$571k
NCI NIH HHS P30 CA014520NCI NIH HHS P30 CA14520NCI NIH HHS R01 CA077158NCI NIH HHS U01 CA077158
6 · The paper itself

Abstract

Decreasing the incidence of nonmelanoma skin cancer (NMSC) is of great importance in regards to future healthcare services. Given the previously reported preventive effects of α-difluoromethylornithine (DFMO) in skin and colon cancer trials, we determined appropriate cause to update the clinical data on the subjects from the recently reported randomized, double-blind, placebo-controlled phase III skin cancer prevention study of DFMO. Our intention was to retrospectively assess the further incidence of skin cancer, other malignancies, and adverse events of patients accrued to our phase III skin cancer prevention study of DFMO. Clinical records of 209 University of Wisconsin (UW) Health subjects were reviewed, and 2,092.7 person years of on study (884.3 person years) and poststudy (1,208.4 person years) follow-up for these patients were assessed for new NMSC events and recurrence rates from the on study period, the poststudy period, and the two study periods combined. No evidence of increased significant diagnoses or serious adverse events was observed in the DFMO participants. The initially observed, marginally significant reduction (P = 0.069) in NMSC rates for DFMO subjects relative to placebo continued without evidence of rebound. Event rates after discontinuation from study for total NMSCs (DFMO 0.236 NMSC/person/year, placebo 0.297, P = 0.48) or the subtypes of basal cell carcinomas (BCC; DFMO 0.179 BCC/person/year, placebo 0.190, P = 0.77) and squamous cell carcinomas (SCC; DFMO 0.057 SCC/person/year, placebo 0.107, P = 0.43) are listed. Follow-up data revealed a persistent but insignificant reduction in new NMSCs occurring in DFMO subjects without evidence of latent or cumulative toxicity relative to placebo subjects.

Indexed as

AdultAgedBasal Cell CarcinomaCarcinoma, Squamous CellDouble-Blind MethodEflornithineFemaleFollow-Up StudiesHumansIncidenceMaleMiddle AgedPlacebosSkin NeoplasmsWisconsinEflornithinePlacebos

Identifiers

PMID23060038
PMCPMC3518692
OpenAlexW2171994341

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.